1. Field of the Invention
The present invention relates to a vascular suction device, a dilator and a stapler for the closure of a puncture made in the wall of an artery or vein during a medical procedure. The present invention has particular utility for use in and around the femoral artery during and after coronary/cardiac procedures. Other utilities include soft-tissue anchoring, meniscal repair, thoracic lung closure, endoscopic procedures, esophageal repair, laparoscopy, skin/epidermal wound closure and general tissue closure.
2. Description of Related Art
Surgical stapling instruments, dilators and cannulas for diagnostic, interventional and/or therapeutic medical procedures are known. For example, U.S. Pat. No. 5,709,335 issued to Heck discloses a wholly distal surgical stapling instrument for stapling a tubular tissue structure to a luminal structure, such as a vascular lumen. This device can be used for anastomotic stapling of a tubular vessel having two untethered ends, and is especially useful for making the primary anastomotic connection of a bypass vein to a coronary artery or to the aorta. The device essentially includes a rod that is placed within the tubular vessel and an anvil that forces staples (associated with the rod) to bend outwardly against the vessel and a target (such as a coronary artery). Thus, this device requires that the stapler device be placed within the tubular vessel (e.g., vein or artery) for operation. While this device is useful when stapling a graft vein or the like, unfortunately, this device would be inappropriate when the entirety of the tubular tissue is not accessible, such as following percutaneous catheterization procedures.
Another example can be found in U.S. Pat. No. 5,403,333 issued to Kaster et al. This patent discloses a side-to-end anastomotic staple apparatus for use where the end of a blood vessel becomes connected to the side or wall of a second blood vessel or other structure, such as the heart. Similar to the previous discussion, this device requires that at least one end of the vessel be open, so that a stapling mechanism can be inserted therethrough. As noted above, many surgical procedures only access a portion of the vessel. Thus, this device would not be useful in these circumstances.
Yet another example, U.S. Pat. No. 5,695,504 issued to Gifford, III et al., discloses an end-to-side vascular anastomosis device to perform end-to-side anastomosis between a graft vessel and the wall of a target vessel. This device involves a procedure in which the end of a graft vessel is passed through an inner sleeve of the device until the end of the vessel extends from the distal end of the device. The distal end of the graft is then affixed to the wall of the target, using a staple and stapler which forces a staple into both tissues. Similar to the previous disclosures, this device is useful for the attachment of one tubular tissue onto another, however, is inadequate in sealing a puncture in an artery, vein or other tissue left by certain medical procedures.
Other examples can be found in the art. However, these devices are often complicated to manufacture and use, requiring expensive tooling and materials. It is often the case that staplers, cannulas and dilators are single application or procedure devices, which must be discarded after use. Thus, there is a need to provide an efficient stapler mechanism that is simple to use and relatively easy to manufacture, since the device is likely to be discarded after only one use. Moreover, the prior art has failed to provide a device that permits a doctor or clinician to gain access to a puncture site and remain centered on that site throughout the entire procedure, including closure of the puncture, or to ensure that the closure mechanism is delivered over and/or around the puncture site.